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Microtubule Inhibitor
Tirbanibulin Ointment for Basal Cell Carcinoma
Phase 2
Recruiting
Led By Edward Lain, MD, MBA
Research Sponsored by Austin Institute for Clinical Research
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 26 days for subjects who completed 1 course of treatment and 51 days for subjects who completed 2 courses of treatment
Awards & highlights
Study Summary
This trial tests a new ointment to treat superficial basal cell carcinoma on the neck, trunk and extremities. It looks at safety and effectiveness.
Who is the study for?
Adults with a single, untreated superficial basal cell carcinoma (sBCC) on the neck, trunk, or limbs (not near hairline or sensitive areas like face/scalp). Participants must be healthy or stable in their condition and willing to avoid sun exposure and certain cosmetics. Women of childbearing age must use effective contraception.Check my eligibility
What is being tested?
The trial is testing Tirbanibulin Ointment 1% for treating sBCC. It's an open-label study where all participants receive the ointment to assess its effectiveness and safety when applied to a specific area of the body affected by cancer.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include local skin reactions such as redness, itching, irritation at the application site; systemic effects are less common but could involve general symptoms like fatigue if absorbed.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 26 days for subjects who completed 1 course of treatment and 51 days for subjects who completed 2 courses of treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~26 days for subjects who completed 1 course of treatment and 51 days for subjects who completed 2 courses of treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Complete clearance rate of sBCC lesion
Side effects data
From 2019 Phase 3 trial • 351 Patients • NCT0328549013%
Application site pain
11%
Application site pruritus
5%
Viral upper respiratory tract infection
4%
Upper respiratory tract infection
2%
Squamous cell carcinoma
2%
Skin abrasion
2%
Basal cell carcinoma
1%
Laceration
1%
Skin ulcer
1%
Tongue disorder
1%
Bacteriuria
1%
Glycosuria
1%
Onychomycosis
1%
Cough
1%
Fall
1%
Back pain
1%
Rosacea
1%
Seborrhoeic keratosis
1%
Contusion
1%
Application site scab
1%
Angular cheilitis
1%
Malignant melanoma in situ
1%
Scab
1%
Headache
1%
Dermatitis
1%
Nodule
1%
Postoperative wound infection
1%
Hypoaesthesia
1%
Blister
1%
Chest pain
1%
Myalgia
1%
Application site inflammation
1%
Pulmonary embolism
1%
Carbuncle
1%
Face injury
1%
Post procedural infection
1%
Haemochromatosis
1%
Urobilinogen urine increased
1%
Melanocytic naevus
1%
Application site nodule
1%
Influenza
1%
Chest discomfort
1%
Non-cardiac chest pain
1%
Application site folliculitis
1%
Bronchitis
1%
Intervertebral disc degeneration
1%
Crystal urine present
1%
Haemangioma of skin
1%
Nasal congestion
1%
Dysgeusia
1%
Ketonuria
1%
Concussion
1%
Sinus congestion
1%
Lentigo
1%
Arthrodesis
1%
Arthropod bite
1%
Skin tightness
1%
Animal bite
1%
Dermatitis contact
1%
Erythema
1%
Diarrhoea
1%
Actinic keratosis
1%
Arrhythmia
1%
Food poisoning
1%
Seasonal allergy
1%
Cellulitis
1%
Urinary tract infection
1%
Pyuria
1%
Tooth infection
1%
Cardiac murmur
1%
Renal cancer recurrent
1%
Hypertension
1%
Colon cancer
1%
Proteinuria
100%
80%
60%
40%
20%
0%
Study treatment Arm
KX2-391 Ointment 1%
Placebo
Trial Design
2Treatment groups
Experimental Treatment
Group I: 5 Day treatment course 2 with Tirbanibulin Ointment 1%Experimental Treatment1 Intervention
Subjects with unresolved lesion will be given an additional study kit containing single-dose packets of Tirbanibulin Ointment 1% and instructed to topically apply to the treatment area once daily for 5 consecutive days.
Group II: 5 Day treatment course 1 with Tirbanibulin Ointment 1%Experimental Treatment1 Intervention
10 Subjects will be given one study kit containing single-dose packets of Tirbanibulin Ointment 1% and instructed to topically apply to the treatment area once daily for 5 consecutive days.
Find a Location
Who is running the clinical trial?
Austin Institute for Clinical ResearchLead Sponsor
4 Previous Clinical Trials
135 Total Patients Enrolled
Edward Lain, MD, MBAPrincipal InvestigatorAustin Institute for Clinical Research
5 Previous Clinical Trials
166 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have recently been treated with specific medications or therapies.My treatment is for a specific part of my body.I am healthy or have a stable medical condition.I do not have any uncontrolled or serious health conditions.I am postmenopausal, surgically sterile, or using contraception.I have a specific skin condition.I am not pregnant or nursing.I expect to be hospitalized or need surgery during the study.I am 18 years old or older.I am willing and able to sign the consent and HIPAA forms.I have a new skin cancer spot on my neck, trunk, or limbs.The area around my lesion is free from significant physical abnormalities.I am generally healthy or my medical condition is stable.I agree to use barrier methods for contraception.I haven't taken certain medications recently.I am willing to stop using moisturizers, sunscreens, and cosmetics on the treatment area.
Research Study Groups:
This trial has the following groups:- Group 1: 5 Day treatment course 2 with Tirbanibulin Ointment 1%
- Group 2: 5 Day treatment course 1 with Tirbanibulin Ointment 1%
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are being selected to participate in this experiment?
"Affirmative, the clinicaltrial.gov website signals that this medical trial is currently looking for participants. This study, which was published on April 17th 2023, requires the recruitment of 10 individuals from a single site."
Answered by AI
Is enrollment still open for those interested in taking part in this experiment?
"Indeed, clinicaltrials.gov verifies that this research is actively recruiting participants. Initially posted on April 17th 2023 and lately updated June 19th of the same year, the study needs to enroll 10 individuals at 1 medical institution."
Answered by AI
How hazardous is the five-day regimen of Tirbanibulin Ointment 1% to those participating?
"Our team assessed the safety of a 5 day course with Tirbanibulin Ointment 1% to be 2, as Phase 2 trials typically supply some evidence for its safety but not its effectiveness."
Answered by AI
Who else is applying?
What portion of applicants met pre-screening criteria?
Did not meet criteria
Why did patients apply to this trial?
The cost of Tirbanibin. I have 3-5 AK’s on my face that my doctor wants to treat with cryotherapy and I’m afraid of scarring.
PatientReceived 1 prior treatment
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